SPL v6
SPL
SPL Set ID 3e65e67d-c7d0-2fcb-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-10-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Sodium Laureth Sulfate Cocamidopropyl Betaine Sodium Chloride Glycerin Ditetracycline Tetrasodium Edetate Methylchloroisothiazolinone Methylisothiazolinone Fd&c Yellow No. 5 Fd&c Red No. 4

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-10-08

Description

Benzalkonium Chloride - 0.13%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Uses for handwashing or decrease bacteria to the skin

Dosage and Administration

Direction

  • wet hands
  • apply palmful to hands
  • scrub thoroughly
  • rinse
Description

Benzalkonium Chloride - 0.13%

Section 50565-1

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask a doctor if irritation or redness develops

Section 50567-7

When using this product

  • do not get it into eyes. If contact occurs, rinse eye thoroughly with water
Section 51727-6

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow# 5 (Cl 19140), Red# 4 (Cl 14700)

Section 51945-4

Section 55105-1

Purpose: Antibacterial

Section 55106-9

Benzalkonium Chloride - 0.13%


Structured Label Content

Indications and Usage (34067-9)

Uses for handwashing or decrease bacteria to the skin

Dosage and Administration (34068-7)

Direction

  • wet hands
  • apply palmful to hands
  • scrub thoroughly
  • rinse
Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develops

Section 50567-7 (50567-7)

When using this product

  • do not get it into eyes. If contact occurs, rinse eye thoroughly with water
Section 51727-6 (51727-6)

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow# 5 (Cl 19140), Red# 4 (Cl 14700)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Antibacterial

Section 55106-9 (55106-9)

Benzalkonium Chloride - 0.13%


Advanced Ingredient Data


Raw Label Data

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